Early Development Global Regulatory Lead

Desired Skills and Experiencenice to have

• Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on major regulatory regions such as FDA, EMA, or PMDA.

• Advanced scientific degree preferred, such as PhD or PharmD.

• Resonates with argenx values and culture, with a collaborative, humble and accountable approach to working across the organization.

• Strong understanding of drug development, with direct experience in early clinical development, first-in-human studies, orphan drugs and regulatory strategy for innovative medicines.

• Proven ability to develop fit-for-purpose global regulatory strategies that support early asset progression, regulatory interactions and informed development decisions.

• Regulatory experience across early and late clinical development phases, supporting continuity from discovery and first-in-human studies through later-stage development.

• Experience interacting with regulatory authorities, including scientific advice, IND/CTA activities, expedited pathways and other early development regulatory milestones.

• Strong scientific mindset, with the ability to engage credibly with scientists, clinicians and cross-functional development teams.

• Scientific depth in immunology is highly desirable, with broader experience across therapeutic areas, indications considered an advantage.

• Complementary expertise across modalities, including antibodies, peptides, siRNA, and small molecules.

• Experience integrating biomarker strategy, patient engagement and patient-relevant evidence into regulatory and development plans.

• Strong understanding of current and evolving global regulations, guidelines, and regulatory expectations and health care business practices relevant to early and late clinical development globally.

• Clear and influential communicator, with strong written, verbal and presentation skills and the ability to translate complex regulatory topics into practical business recommendations.

• Highly developed organizational and project management skills, with the ability to prioritize, delegate and manage multiple workstreams in a fast-paced environment.

• Strong matrix leadership skills, with the ability to build relationships, influence stakeholders, build, motivate and develop teams, and drive outcomes.

• Pragmatic, creative and hands-on, combining strategic thinking with the ability to execute and deliver high-quality work under challenging timelines.

• Additional experience supporting cross-functional business development due diligence activities and providing regulatory assessments to support investment and portfolio decisions is an advantage.

• Interest in applying AI and digital tools to improve regulatory strategy, regulatory intelligence, document preparation and ways of working is an strong advantage.

• Short-term and long-term incentive program eligibility